Label: HEMP WITH FLOURIDE, SPEARMINT- sodium monofluorophosphate paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated June 19, 2020

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  • ACTIVE INGREDIENT

    Sodium monofluorophosphate 0.76% (0.13% w/v fluoride ion) . . . Anticavity

  • PURPOSE

    aids in the prevention of dental cavities

  • WARNINGS

    Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    adults and children 2 years of age and older: brush teeth thoroughly, preferably after each meal or at least twice per day, or as directed by a dentist or doctor. * instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). * supervise children as necessary until capable of using without supervision. * children under 2 years of age: Consult a dentist or doctor.

  • OTHER SAFETY INFORMATION

    Tamper evident, use only if box seal is intact. Keep tube capped when not in use. When using this product, if irritation occurs, discontinue use. Keep out of reach of children.

  • INACTIVE INGREDIENT

    glycerin, water, calcium carbonate, hydrated silica, xylitol, sodium bicarbonate, carrageenan, cannabis sativa (hemp) seed oil, sodium sauroyl sarcosinate, natural flavor, zinc citrate, benzyl alcohol

  • PRINCIPAL DISPLAY PANEL

    Sample Artwork

  • INGREDIENTS AND APPEARANCE
    HEMP WITH FLOURIDE, SPEARMINT 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62721-0030
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.76 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    WATER (UNII: 059QF0KO0R)  
    ZINC CITRATE (UNII: K72I3DEX9B)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    XYLITOL (UNII: VCQ006KQ1E)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    Product Characteristics
    Colorwhite (Off white) Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62721-0030-9156 g in 1 TUBE; Type 0: Not a Combination Product06/19/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35506/19/2020
    Labeler - Lornamead (126440440)
    Registrant - Lornamead (080046418)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lornamead080046418manufacture(62721-0030)
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